Zydus Lifesciences Ltd on Thursday said it has received final approval from the US health regulator to market its generic version of Dapsone gel used to treat acne.
The final approval by the US Food and Drug Administration (USFDA) is for Dapsone gel of strength 7.5 per cent, Zydus Lifesciences said in a regulatory filing.
Dapsone gel is used to treat acne and will be manufactured at the group’s topical manufacturing facility in Changodar, Ahmedabad, it added.
Dapsone gel, 7.5 per cent had annual sales of USD 35.8 million in the US, Zydus Lifesciences said citing IQVIA MAT March 2024 data.